Pembrolizumab + Lenvatinib: Non-clear Cell RCC Trial Results Posted

Trial results for the combination of pembrolizumab (Keytruda) and lenvatinib in subjects with locally advanced or metastatic non-clear cell renal cell carcinoma were posted on ClinicalTrials.gov on 2025-03-21. The Phase 2 study, NCT04267120, reported an Overall Response Rate (ORR) in 4 of the 11 enrolled participants.

Background

Pembrolizumab, also known as Keytruda, is an immunotherapy drug. This study investigated its use in combination with lenvatinib for the treatment of renal cell carcinoma, specifically the non-clear cell subtype. The trial explored this combination in patients who had not received prior chemotherapy for advanced disease.

Trial design

The LENKYN Trial (NCT04267120) was a Phase 2, single-arm, multicenter study that enrolled 11 participants. The trial investigated the combination of lenvatinib (20 mg/day) and pembrolizumab (200 mg every 3 weeks) in subjects with unresectable advanced or metastatic non-clear cell renal cell carcinoma who had not received any chemotherapy for advanced disease. The study's overall status is TERMINATED.

Key results

The trial reported on the Overall Response Rate (ORR) and safety and tolerability. For the outcome of Overall Response Rate (ORR) in the Lenvatinib + Pembrolizumab group, 4 Participants achieved a response. Safety and tolerability of the regimen were also measured by related adverse events experienced by participants. Counts of participants experiencing various related adverse events included 2 Participants, 1 Participant, 3 Participants, and 5 Participants, among others.

What this means

The results from this Phase 2 trial provide initial data on the combination of pembrolizumab and lenvatinib in non-clear cell renal cell carcinoma. With an Overall Response Rate in 4 of 11 participants, these findings offer an early indication of activity. However, the study was TERMINATED, and the small enrollment size means these results are preliminary and require further investigation in larger trials to fully assess efficacy and safety.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04267120, titled "Lenvatinib (LEN) in Combination With Pembrolizumab (KEYtruda) in Subjects With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma (The LENKYN Trial)," were posted on 2025-03-21 on clinicaltrials.gov.